Checking registration before the entry moves
Registrations lapse quietly. The entry carries whatever data it was given, and nobody discovers the problem until the cargo is on the ground.
Licensed U.S. customs brokerage. Customs broker of record; movement coordinated through vetted partners.
Registration verification is the check that a foreign facility's FDA registration is current and that the manufacturer and facility details transmitted with an entry match the shipment. Many FDA-regulated products require the producing facility to be registered, and an entry citing lapsed or mismatched registration data is a common cause of delay.
Key takeaways
- Many FDA-regulated products require the producing facility to hold a current registration.
- Registrations require periodic renewal and lapse without warning to the importer.
- The facility named at entry must be the facility that actually produced the goods.
- A mismatch between registration data and shipment data reads as an error, whatever the cause.
- Correcting a registration is regulatory work, not entry work.
What gets checked
Whether the producing facility appears registered. Whether that registration is current rather than expired. Whether the facility named on the entry is the facility that actually made the goods — which is not always the one on the invoice. And whether the details transmitted match the registration record rather than approximating it.
When it turns out to be a regulatory problem
If a registration has lapsed, been cancelled, or was never obtained, that is not something an entry filing fixes. It needs correcting at source, and that is regulatory work rather than brokerage work.
We will tell you plainly when that is the position. Where specialised FDA regulatory support is needed, additional assistance can be coordinated through affiliated service providers.
How it works
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01
Facility identified
Which facility actually produced the goods, which is not always the invoicing party.
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02
Registration checked
Present, current, and matching the facility named on the entry.
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03
Details reconciled
Address and identifiers compared against the registration record.
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04
Discrepancies raised
Before transmission, while there is still time to resolve them.
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05
Data transmitted
Verified rather than transcribed.
Common mistakes
- Assuming a registration obtained once stays valid. Renewal is periodic and easy to miss.
- Naming the trading company rather than the producing facility. They are frequently different.
- Approximating the address. If it does not match the record, it reads as the wrong facility.
- Discovering the problem at arrival. Registration issues are slow to fix and cargo waits.
- Expecting the entry filing to resolve it. A lapsed registration is corrected at source, not in the declaration.
Questions
Which facilities need to be registered?
It depends on the product category. Food facilities, drug establishments and device establishments have their own registration frameworks, and requirements differ by product type. Confirming before the first shipment is far cheaper than confirming at the port.
How often do registrations need renewing?
Renewal periods vary by category. What matters commercially is that they do expire, and the importer is usually not the party notified when they do.
What if the registration has lapsed?
The shipment is likely to be held, and the registration must be corrected at source. That is regulatory work rather than entry work — we will tell you so rather than billing to work on something outside our scope.
Can you check registration before I place an order?
Yes, and that is the sensible point to do it. Confirming a supplier's registration status before committing to a purchase is considerably cheaper than discovering it after the goods ship.
Related
Tell us what you're importing.
Commodity, origin, port and arrival date is enough to start.